in 150 - 200 words summarize and rephrase this article, and write one sentence the most takeaway and one-sentence criticism from this article (The Ethics of Using Quality Improvement Methods in Health Care)

Abstract

Quality improvement (QI) activities can improve health care but must be conducted ethically. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations protecting human subjects of research. The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings and concluded that QI is an intrinsic part of normal health care operations. Both clinicians and patients have an ethical responsibility to participate in QI, provided that it complies with specified ethical requirements. Most QI activities are not human subjects research and should not undergo review by an institutional review board; rather, appropriately calibrated supervision of QI activities should be part of professional supervision of clinical practice. The group formulated a framework that would use key characteristics of a project and its context to categorize it as QI, human subjects research, or both, with the potential of a customized institutional review board process for the overlap category. The group recommended a period of innovation and evaluation to refine the framework for ethical conduct of QI and to integrate that framework into clinical practice.

Americans expect high-quality health caresafe, effective, patient-centered, timely, equitable, and efficient (1). Unfortunately, reality falls short of this ideal. A growing literature documents serious problems, such as unnecessary surgery, inappropriate use of medications, inadequate prevention, avoidable exacerbations of chronic conditions, and long delays before important research findings become standard (14).

We discuss deliberate efforts of providers to meet their obligations to improve the quality of patient care through clinical and managerial changes in the processes of care. Health care practices have always evolved, but mostly in a scattershot way. In recent years, providers have initiated new methods, some of which were modeled first in manufacturing to make ongoing improvements more systematic, data-guided, and efficient (5, 6). These continuous quality improvement methods are commonly referred to as QI.

The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings. Quality improvement uses an array of methods and can look like practical problem solving, an evidence-based management style, or an application of a theory-driven science of system change. Quality improvement methods often encourage health care workers to use their experience, along with insights from others, to identify promising improvements, implement changes on a small scale, monitor and interpret effects, and decide about additional changes and wider implementation. Alternatively, a QI activity might start with management review of the organization's performance from aggregate data or with similar analyses of data across multiple organizations. At its heart, QI is a form of experiential learning that regards improvement to be part of the work process and always involves deliberate actions expected to improve care, guided by data reflecting the effects.

Recommendations for Action summarizes a broad agenda for implementing accountability for the ethical conduct of QI. The fourth recommendation in Table 3 (to develop new models of internal management and supervision of QI and of QIhuman subjects research overlap projects) requires additional discussion. We recommend that the arrangements for internal management of QI and overlap activities discussed in brief here and in the full report (8) be translated into models that work in real health care settings, through collaborative efforts by organizations that are leaders in QI. The OHRP could encourage some organizations to undertake this task, or QI organizations could take the initiative themselves, with central coordination.